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Medical Ultrasound Gel

EUDAMED

Class I (EU MDR)

Ref 5KG TABRef 250g netural englishRef 4L livingstoneRef 5L MSL

by Shanghai Shenfeng Medical&Health Articles Co., Ltd

Identity

Trade Name
Medical Ultrasound Gel EUDAMED
Device Name
Medical Ultrasound Gel EUDAMED
Model / Reference
5KG TAB EUDAMED
250g netural english EUDAMED
4L livingstone EUDAMED
5L MSL EUDAMED

Identifiers

Primary DI / UDI-DI
06950689130137 EUDAMED
06950689130144 EUDAMED
06950689130175 EUDAMED
06950689130199 EUDAMED
Basic UDI-DI
69506891GEL002LX EUDAMED
EMDN Code
Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Türkiye EUDAMED
Poland EUDAMED
Cyprus EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Medical Ultrasound Gel by Shanghai Shenfeng Medical&Health Articles Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000012676
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 98c1b7c8-0b93-4bdb-a24f-a6214fda92b7 61 fields · synced Oct 6, 2026
  • EUDAMED 3310f14b-dfe3-457a-bf60-ee94cd2385d9 61 fields · synced May 17, 2026
  • EUDAMED 17fb0bc7-26ff-43a5-8da2-28a4d89f02a7 61 fields · synced May 17, 2026
  • EUDAMED 296676ce-4c19-48b4-9919-e8d5d775fd6a 61 fields · synced May 18, 2026